What We Do So Well

GBI offers a full range of mammalian cell culture development and manufacturing services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to processes for licensed manufacturing.

An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. GBI has established procedures for evaluation of all GMP areas and processes to ensure continuous control. Sterility testing on all final vialed products is outsourced to a qualified independent safety testing lab to provide to our clients additional and objective assurance that their products have been manufactured and are safe in accordance with USP and CFR testing requirements. Bacteristasis and Fungistasis is determined the first time a product is analyzed to ensure valid measurement of sterility testing parameters.

Endotoxin is monitored for all buffers and equipment rinses and at defined stages for in- process and final product manufacturing. Total organic carbon (TOC) is also assessed for all water system points of use and equipment cleaning processes to ensure that the equipment and materials used are clean and free of all residues from previous products.

GBI offers:

• Our staff has decades of analytical experience analyzing of biological materials.
• Experience of performing testing on over 150 recombinant proteins and monoclonal antibodies
• Experienced in handling FDA and EU regulatory agency inspections
• Preparation or review of IND submission documentation (CMC sections)